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The primary study objective is to assess the feasibility of using the MindFrame System to safely and effectively restore blood flow in a thrombotic neurovascular occlusion in patients experiencing an ischemic stroke.
The objective of PRIISM is to assess the feasibility of using the MindFrame System to safely and effectively restore blood flow in a thrombotic neurovascular occlusion in patients with acute ischemic stroke. Safety will be assessed by the device-related serious event rate as it compares to other similar therapies. The events include but are not limited to symptomatic hemorrhage, vessel dissection, embolization and overall morbidity and mortality. Target vessels include the basilar, internal carotid and middle cerebral (M1 and M2 segments) arteries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment Arm | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MindFrame System | Device | Thrombectomy Catheter designed to rapidly restore blood flow in patients experiencing an ischemic stroke |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical Device Success by as Assessed by the Percentage of Participants Which Established at Least TIMI 2 Flow Upon Deployment of the System Across the Occlusion and Within 30 Minutes of Placing the Guide Catheter. | TIMI Flow is a perfusion scoring system from 0-3 referring to levels of blood flow assessed during reperfusion procedures: TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow | Immediately postprocedure |
| Procedural Success as Determined by the Overal Percentage of Patients Who Achieve TIMI Grade 2/3 Flow, With or Without the Use of Adjuvant Therapy, in All Treatable Vessels as Confirmed by the Final Post Treatment Angiogram. | TIMI Flow is a scoring system from 0-3 referring to levels of blood flow assessed during percutaneous coronary angioplasty: TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow | Immediately postprocedure |
| Clinical Success | Clinical Success as determined by achievment of a Modified Rankin Scale score of 0-2 at 90 days postprocedure. The modified Rankin Scale is a measure of a patient's level of functional independence with 0=normal and 6-death. Patients with a score of 0-2 are considered functionally independent. | 90 days postprocedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Device-related Serious Adverse Events | Evaluation of the safety of using the MindFrame System based on device-related serious adverse event(s). Device-related serious adverse events are defined as vessel perforation, intramural arterial dissection, device-related symptomatic intracranial hemorrhage, and significant embolization in a previously uninvolved arterial territory. | Treatment to 90 days postprocedure |
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Inclusion Criteria:
NIHSS 6 to 30 within 6 hours of symptom onset
Pre-stroke Modified Rankin Score ≤ 2
Large Vessel Occlusion
Patient/patient guardian is willing to comply with the protocol requirements and return to the treatment center for all required clinical evaluation.
Patients must meet at least one of the following criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martin Bendszus, MD, PhD | Heidelberg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Heidelberg | Heidelberg | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | MindFrame System Treatment Group | All participants with acute ischemic stroke who were treated with the 1st generation MindFrame System of neurothrombotic stent retrievers. The first generation MindFrame System was a self-expanding nitinol stent retriever mounted on a hypotube delivery wire and delivered to the occlusion site via a 0.027 inch microcatheter. Eligible patients were aged 18-80 years, had a baseline NIHSS score of 6-30, had a thrombotic occlusion of the ICA, MCA (M1 or M2) or basilar arteries, and could be treated within 6 hours of stroke onset. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | All participants treated with the Test System |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Technical Device Success by as Assessed by the Percentage of Participants Which Established at Least TIMI 2 Flow Upon Deployment of the System Across the Occlusion and Within 30 Minutes of Placing the Guide Catheter. | TIMI Flow is a perfusion scoring system from 0-3 referring to levels of blood flow assessed during reperfusion procedures: TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow | All participants treated with the Test System | Posted | Number | percentage of participants | Immediately postprocedure |
|
All adverse events up to and including the 90-day follow-up
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | All participants treated with the Test System |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intracranial hemorrhage | Nervous system disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epistaxis | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Thomas J. McCarthy | MindFrame, Inc . | 949-204-0806 | tmccarthy@mindframeinc.com |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| D002544 | Cerebral Infarction |
| D020521 | Stroke |
| D014652 | Vascular Diseases |
| D002493 | Central Nervous System Diseases |
| D001037 | Aphasia |
| D006429 | Hemiplegia |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D009422 | Nervous System Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Mean Baseline National Institutes of Health Stroke Scale (NIHSS) score | The NIH stroke scale (abbreviated NIHSS)is a scale developed by National Institutes of Health that communicates several different neurological deficits upon a single axis, represented by a score from 0 to 42 with "0" being no deficits and "42" being death. | Mean | Standard Deviation | NIHSS units |
|
| Median Baseline NIHSS score | The NIH stroke scale (abbreviated NIHSS)is a scale developed by National Institutes of Health that communicates several different neurological deficits upon a single axis, represented by a score from 0 to 42 with "0" being no deficits and "42" being death. | Median | Full Range | NIHSS units |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | Procedural Success as Determined by the Overal Percentage of Patients Who Achieve TIMI Grade 2/3 Flow, With or Without the Use of Adjuvant Therapy, in All Treatable Vessels as Confirmed by the Final Post Treatment Angiogram. | TIMI Flow is a scoring system from 0-3 referring to levels of blood flow assessed during percutaneous coronary angioplasty: TIMI 0 flow (no perfusion) TIMI 1 flow (penetration without perfusion) TIMI 2 flow (partial reperfusion) TIMI 3 flow (complete perfusion) is normal flow | Percentage of participants who achieved (TIMI/TICI grade 2/3 flow), with or without the use of adjuvant therapy, in all treatable vessels as confirmed by the final post treatment angiogram. | Posted | Number | percentage of participants | Immediately postprocedure |
|
|
|
| Primary | Clinical Success | Clinical Success as determined by achievment of a Modified Rankin Scale score of 0-2 at 90 days postprocedure. The modified Rankin Scale is a measure of a patient's level of functional independence with 0=normal and 6-death. Patients with a score of 0-2 are considered functionally independent. | Percentage of participants achieving a Modified Rankin Scale score of 0-2 at 90 days postprocedure. | Posted | Number | percentage of participants | 90 days postprocedure |
|
|
|
| Secondary | Number of Device-related Serious Adverse Events | Evaluation of the safety of using the MindFrame System based on device-related serious adverse event(s). Device-related serious adverse events are defined as vessel perforation, intramural arterial dissection, device-related symptomatic intracranial hemorrhage, and significant embolization in a previously uninvolved arterial territory. | Per protocol analysis of all participants treated with the 1st generation MindFrame System of neurothrombotic stent retrievers. | Posted | Number | events | Treatment to 90 days postprocedure |
|
|
|
| 14 |
| 40 |
| 12 |
| 40 |
| Death | General disorders | Systematic Assessment |
|
| Disorientation | Nervous system disorders | Systematic Assessment |
|
| Malignant infarction | Nervous system disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
|
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| D020520 | Brain Infarction |
| D002545 | Brain Ischemia |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D013064 | Speech Disorders |
| D007806 | Language Disorders |
| D003147 | Communication Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010243 | Paralysis |